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Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes

Primary Purpose

Dyslipidemia, Type II Diabetes

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YH14755
Metformin
Rosuvastatin
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed Informed Consent
  • Subjects with Dyslipidemia and Type II Diabetes
  • 6.5% ≤ HbA1c level ≤ 9.0% and LDL-C level ≤ 250mg/dL(6.5 nmal/L) at screening
  • BMI ≤ 45kg/m2
  • Subjects who dose not administered diabetes treatment at least 4 weeks prior to screening visit.
  • 19 years later, men and women under the age of 75

Exclusion Criteria:

  • Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
  • Subject with type I Diabetes
  • Subject with hypertension which does not controlled by treatment(have blood pressure > 160/110mmHg)
  • Have a known allergy to drugs
  • Have administered Cyclosporine
  • Have administered Obesity treatment within 12 weeks prior to screening visit
  • Participated in any other clinical trials within 30 days prior to the first administration
  • Subject who is judged to be ineligible by investigator

Sites / Locations

  • Seoul National Universitiy Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

YH14755

Metformin

Rosuvastatin

Arm Description

PO, Once Daily, 16 weeks

PO, Once Daily, 16 weeks

PO, Once Daily, 16 weeks

Outcomes

Primary Outcome Measures

Change in LDL Cholesterol
Change in HbA1c

Secondary Outcome Measures

Full Information

First Posted
September 22, 2015
Last Updated
October 2, 2018
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02586129
Brief Title
Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
Official Title
Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 4, 2015 (Actual)
Primary Completion Date
July 7, 2017 (Actual)
Study Completion Date
July 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.
Detailed Description
This is a phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes. In YH14755 treatment group, 88 subjects will be assigned and the subjects administer YH14755 for 16 weeks. In Metformin treatment group, 88 subjects will be assigned and the subjects administer Metformin for 16 weeks. In Rosuvastatin treatment group, 88 subjects will be assigned and the subjects administer Rosuvastatin for 16 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Type II Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YH14755
Arm Type
Experimental
Arm Description
PO, Once Daily, 16 weeks
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
PO, Once Daily, 16 weeks
Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Description
PO, Once Daily, 16 weeks
Intervention Type
Drug
Intervention Name(s)
YH14755
Intervention Description
20/1500mg, QD
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
1500mg, QD
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
20mg, QD
Primary Outcome Measure Information:
Title
Change in LDL Cholesterol
Time Frame
Change from baseline at 16 weeks
Title
Change in HbA1c
Time Frame
Change from baseline at 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent Subjects with Dyslipidemia and Type II Diabetes 6.5% ≤ HbA1c level ≤ 9.0% and LDL-C level ≤ 250mg/dL(6.5 nmal/L) at screening BMI ≤ 45kg/m2 Subjects who dose not administered diabetes treatment at least 4 weeks prior to screening visit. 19 years later, men and women under the age of 75 Exclusion Criteria: Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study Subject with type I Diabetes Subject with hypertension which does not controlled by treatment(have blood pressure > 160/110mmHg) Have a known allergy to drugs Have administered Cyclosporine Have administered Obesity treatment within 12 weeks prior to screening visit Participated in any other clinical trials within 30 days prior to the first administration Subject who is judged to be ineligible by investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakcheol Jang, M.D., Ph.D.
Organizational Affiliation
Department of Internal Medicine, SNU Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National Universitiy Bundang Hospital
City
Seongnam-Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes

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